The first phase of the trial to investigate the safety and efficacy of intratumoral administration of optimized measles virus in patients with pancreatic cancer
En Using optimized measles virus as a safe and effective method along other treatment methods to control the pancreatic tumor
Design
The clinical trial has a control group, with parallel groups, without blinding, randomized, phase 1 on 15 patients. Using online randomization website.
Settings and conduct
This investigational study is going to be conduct in Gastroenterology and Liver Research Center and Baqiyatallah hospital. The patient will receive 5 cc of the liquid containing the optimized Measles vaccine intratumorally within standard treatments at the same time.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1-Ovarian cancer confirmed as treatment-resistant by gastroenterologist 2-Age between 18 and 85 years . 3-The ability to understand and sign the consent form by patient or patients spouse, parent or guardian Exclusion criteria: 1-Any difficulty in liver, kidney and bone marrows function. 2-Failure to cooperate in performing the required protocol, such as gathering samples and visiting for clinical study. 3-Any Infection, autoimmune disease or immune system weakness.
Intervention groups
The under care group will receive 4 doses of the optimized measles virus vaccine intratumorally every week. Control group will receive only the standard treatments and will not receive the the optimized measles virus vaccine intratumorally.
Main outcome variables
Fever, pain in the abdominal area, nausea, blood factors, liver enzymes, changes in CEA andCA19-9 and tumor size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230903059342N3
Registration date:2024-10-19, 1403/07/28
Registration timing:registered_while_recruiting
Last update:2024-10-19, 1403/07/28
Update count:0
Registration date
2024-10-19, 1403/07/28
Registrant information
Name
Ruhollah Dorostkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8817 0179
Email address
r.dorost@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The first phase of the trial to investigate the safety and efficacy of intratumoral administration of optimized measles virus in patients with pancreatic cancer
Public title
Evaluation of pancreatic cancer treatment by optimized measles vaccine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of the patient's cancer by a gastroenterologist
Patient age 18 to 85
Absence of pregnancy
Proper functioning of liver, kidney and bone marrow
The ability to understand and sign the consent form by the patient and one of these cases: the patient's spouse, parent or guardian.
Complying with all protocol steps including sample submission and returning to the clinical study site for subsequent visits
Absence of autoimmune diseases or diseases of the immune system
Exclusion criteria:
Life-threatening acute infection
Absence of any previous record that describes the doctor's treatment and orders were nor followed by patient.
Using drugs that weaken the immune system
Affected by any diseases that disturbs the immune system
Having any previous record of organ transplantation
Allergy to measles vaccine
pregnancy
Using other investigational treatments at the same time
Age
From 18 years old to 85 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is going to be done by the method of random blocks of 6 random strings with a length of 15 coincidences with a ratio of 2 to 1.
This string is created by one of the online randomization software.
In order to hide the randomization, the method of closed envelopes will be used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in the Research Institute of Gastrointestinal and Liver Diseases of Shahid Beheshti
Street address
Institute of Gastrointestinal and Liver Diseases, In the yard of Taleghani Hospital, Arabi St., Yemen St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2024-05-15, 1403/02/26
Ethics committee reference number
IR.SBMU.RIGLD.REC.1403.026
Health conditions studied
1
Description of health condition studied
pancreatic cancer
ICD-10 code
C25.9
ICD-10 code description
Malignant neoplasm of pancreas, unspecified
Primary outcomes
1
Description
Fever
Timepoint
Hourly in the first 24 hours and then daily up to 7 days
Method of measurement
Thermometer
2
Description
Examining changes in the patient's heart condition
Timepoint
Hourly after the start of treatment for up to 7 days
Method of measurement
Electrocardiogram
3
Description
Examining changes in the patient's breathing status
Timepoint
Hourly in the first 24 hours and then daily up to 7 days
Method of measurement
pulse oximeter
4
Description
Examining the amount of CEA & CA19-9 cancer antigen in the blood
Timepoint
Weekly until 3 months after the end of treatment
Method of measurement
Blood test
5
Description
Examination of tumor size
Timepoint
Weekly until 3 months after the end of treatment
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: includes patients who, in addition to standard treatment, receive the optimized measles vaccine that designed and optimized by Baqiyatullah university intraperitoneally in four doses weekly. At the same time as being treated with the optimized measles vaccine, the patient receives standard treatments including chemotherapy and immunotherapy. In fact, the intervention is in the form of adjuvant therapy.
Category
Treatment - Other
2
Description
Control group: They receive only standard treatment including chemotherapy and immunotherapy and no intervention is done in their standard treatment.
Research Institute of Gastrointestinal and Liver Diseases, Shahid Beheshti University of Medical Sci
Full name of responsible person
Amir Sadeghi
Street address
Digestive and Liver Diseases Research Institute of Shahid Beheshti University of Medical Sciences, in the yard of Taleghani Hospital, Arabi Street, Yemen Street, Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2516
Fax
+98 21 2243 2517
Email
R.dorost@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Digestive and Liver Diseases Research Institute of Shahid Beheshti University of Medical Sciences, in the yard of Taleghani Hospital, Arabi Street, Yemen Street, Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2516
Fax
+98 21 2243 2517
Email
R.dorost@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Assistant of Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ruhollah Dorostkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Virology Lab. Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak Sq, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8817 0179
Fax
Email
R.dorost@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ruhollah Dorostkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Virology Lab. Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak Sq, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8817 0179
Fax
Email
R.dorost@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ruhollah Dorostkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Virology
Street address
Virology Lab. Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak Sq, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8817 0179
Fax
Email
R.dorost@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available